Method of manufacturing ostomy pouches

ABSTRACT

Ostomy pouches are manufactured by partially contour welding two pouch walls one of which has a stoma aperture over an area extending from the top edge of the pouch past the region of the weld seam around the aperture. A separator member is inserted into the partially welded pouch and an adhesive label is then welded or bonded to the pouch wall around the aperture. The separator member is withdrawn and the contour welding is completed to form the completed pouch.

BACKGROUND OF THE INVENTION

Ostomy pouches are known in a series of different shapes and sizesadapted according to their purpose. However, it is a common feature thatthey ordinarily consist of two pouch walls welded together along theircontour. One of the walls has an aperture which receives materialdischarged from the stoma. An adhesive label or faceplate is affixed tothe pouch wall around the stomal aperture by welding or adhesion. Theadhesive label permits the detachable fastening of the pouch on theuser's body around stoma.

In the production of such ostomy pouches, the starting material used isgenerally two webs of weldable plastic sheet material that are advancedstepwise through an apparatus with three stations. The first station hasa punching tool to produce the apertures in one of the webs, theadhesive label being welded onto said web around the apertures at thesecond station, and the two webs being subsequently brought together andunited along a line corresponding to the wanted contour of the pouch bymeans of an annular welding electrode at the third station. The finishedpouches may simultaneously be separated from the remaining sheetmaterial.

As the contour welding operation cannot be carried out through theadhesive label it is a primary condition in this technique of productionthat the label be positioned entirely within the contour of the pouch.In many cases, this is completely acceptable. However, in other cases,it means that for production reasons the pouch must be made bigger thanotherwise necessary or that the distance from the aperture to the top ofthe pouch must be lengthened. The use of a pouch having such increaseddimensions can result in the upper part of the pouch pulling outwardlyfrom the user's body as a consequence of the increase in weight when thepouch fills.

SUMMARY OF THE INVENTION

This invention is directed to a method of manufacturing ostomy pouchesin which the adhesive label or faceplate can extend past part of or evenpast the whole pouch contour. The particular feature of this methodconsists in that the two pouch walls in a first step are partiallycontour welded together namely over an area extending from the top edgeof the pouch past the region of the weld seam around the aperture. Theadhesive label or faceplate is subsequently applied by welding whileusing a separator member introduced into the partially finished pouch.The separator functions as a base for the pouch wall to which the labelis being welded. The contour welding operation is subsequently completedin a second step after withdrawal of the separator member.

This invention is also directed to the apparatus employed in performingthe method and to the resulting pouch obtained by virtue of this newmethod.

BRIEF DESCRIPTION OF THE DRAWINGS

The method according to the invention is illustrated by the accompanyingdrawings, in which:

FIGS. 1 and 2 are schematic side elevational and plan views,respectively, showing the manufacturing of an ostomy pouch with itscontour only partially overlapped by the adhesive label of the pouch,and

FIGS. 3 and 4 are similar views of the manufacturing of an ostomy pouchwith its contour entirely inside the contour of the label.

DETAILED DESCRIPTION OF THE INVENTION

An object of this invention is to provide a process of manufacture whichallows the adhesive label or faceplate to extend past part of or evenpast the whole pouch contour. In other words, the adhesive label nolonger determines the minimum size of the pouch nor the minimum distancefrom the aperture to the pouch edge. This invention permits themanufacture, for example, of extremely small ostomy pouches that can besafely placed at the stoma, and which, if desired, may serve only as athrough-flow collector connected by a hose to a larger collection pouch.The larger collecting pouch could then be fastened to a place on theuser's body such as around the leg where it will not hamper physicalactivity.

More particularly, this invention relates to a method of manufacturingostomy pouches having two pouch walls welded together along theircontour, one of the two walls being provided with an aperture and anadhesive label or faceplate welded or bonded to the pouch wall aroundsaid aperture which supports the pouch on the user's body. Theparticular feature of this method consists in that the two pouch wallsin a first step are partially contour welded together namely over anarea extending from one edge of the pouch past the region of the weldseam around the aperture. The adhesive label or faceplate issubsequently applied by welding or bonding while using a separatormember introduced into the partially finished pouch. The separatorfunctions as a base for the pouch wall to which the label is beingwelded. The contour welding aperature is subsequently completed in asecond step after withdrawal of the separator member.

While the contour welding operations employed previously where effectedin one step at the completion of the manufacturing process, the sameoperation according to the present invention is divided into two steps.One step is carried out prior and the other subsequent to the attachmentof the adhesive label. The first step comprises welding the portion ofthe pouch contour that is inaccessible to be welded after the adhesivelabel has been applied and leaves a remaining area through which theseparator member is introduced. The separator member is necessary toprevent the two pouch walls from being welded together around theaperture while the label is being welded or bonded to the aperture wall.When the separator member is afterwards withdrawn, the second step ofthe contour welding operation can be effected, thereby completing thepouch by closing the said remaining area. This permits the size andshape of the pouch to be freely chosen without regard to the size of thelabel or faceplate.

When the adhesive label covers only a portion of the pouch wall to whichit is affixed, the first contour welding step can be adjusted so thatthe first weld extends a distance below the area that the pouch has incommon with the adhesive label. The label when welded or bonded in placewill not impede the second contour welding step which completes thepouch contour. However, when the pouch contour is completely within thecontour of the adhesive label, the method is characterized in that thearea for the first contour welding operation extends only a shortdistance past the region of the weld seam which affixes the label aroundthe aperture. The portion of the adhesive label which extends beyondthis region is temporarily lifted clear of the pouch wall as the secondstep of the contour welding is performed.

As shown in FIGS. 1 and 2, two superposed webs 1 and 2 of weldableplastic sheet material are passed stepwise through four stations A, B, Cand D as shown in FIG. 2. Station A comprises a punch 3 and acorresponding matrix 4 to produce an aperture 5 in the uppermost web 1,and guide rollers 6 to guide the lowermost web 2 free of the punch tool3, 4.

At stations B, C and D the two webs run forward across a table or base 7at the same speed, a welding electrode 8 adapted to effect the abovementioned first step of the contour welding of the pouch walls beingpositioned above the right hand end of said table or base, namely instation B. The welded seam produced is indicated by 9 in FIG. 2.

In station C, an adhesive label 10 is placed on the top side of theuppermost web 1 in such a position that a prestamped aperture in thelabel coincides with the aperture 5 in the web or sheet material. At thesame time, a separator member in the form of a flat tongue 11 is pushedinto the pocket limited by the welded seam 9, and the adhesive label 10is connected with the sheet 1 by means of an electrode 12 forming a seam13 following the edge of the aperture 5.

After withdrawal of the tongue 11 from the pocket, the sheets 1 and 2which are united through the welded seam 9, together with the adhesivelabel 10 solely fixed on the sheet 1, are advanced into station D wherethe ostomy pouch is completed. Electrode 14 in station D produces thesupplemental weld seam 9' which together with weld seam 9 forms acompleted or closed contour weld. As shown in FIG. 2, the supplementaryor complementary portion 9' of said contour welding is outside the areaof pouch wall 1 covered by label 10.

In FIGS. 3 and 4 the same reference numerals as in FIGS. 1 and 2 areused for analogous items. The most important difference is that thepouch contour 9, 9' as shown in FIGS. 3 and 4 is entirely placed withinthe contour of the adhesive label 10 so that said label when plane wouldimpede electrode 14 from completing supplemental weld 9'. For thisreason, a stationary guide 15 (shown in FIG. 4) is provided at stationsC and D, to temperarily lift the portion of the adhesive label 10overlying the first-step-welding 9 clear of the sheet, see the uprightflap 16 in station D, thus providing a free working area for theelectrode 14 to produce supplemental weld 9'.

It should be appreciated that the step of punching or cutting apperture5 in the top web 1 could be performed after the first step of thecontour welding. Thus, in the first station a partial contour weld seam9 would be produced. The sheets would advance to a second station wherethe tongue 11 would be inserted, aperture 5 would be cut or punched inthe top sheet 1 and the adhesive label 10 would be welded to the topsheet 1 by means of electrode 12 forming seam 13. After withdrawal oftongue 11, the sheets would be advanced to a third station where thecontour weld 9' is made by electrode 14 so as to complete the pouch. Ofcourse, if necessary, label 10 could be lifted as shown in FIGS. 3 and 4so as not to interfere with electrode 14.

The adhesive label or faceplate 10 is a film of material capable ofbeing welded or bonded by heat or R.F. energy to the pouch wall materialand having a layer of pressure sensitive adhesive that supports thepouch on the body.

It should also be appreciated that aperture 5 need not be completeopening through the pouch wall. A tool could be employed which merelyperforates or weakens the pouch wall along the circumference 5. Theostomate would then remove that portion of the pouch wall prior to usingthe pouch.

What is claimed is:
 1. A method of manufacturing ostomy pouches havingan adhesive label or faceplate that attaches the pouch to the bodycomprising;(a) advancing two superposed webs of weldable plastics sheetmaterial and producing an aperture only in the uppermost web; (b)welding said two webs to form a partial pouch contour said partialcontour extending from the top edge of the pouch past the area of saidaperture in said uppermost web; (c) inserting a separator member intothe partially contour welded pouch to function as a base for saiduppermost pouch wall; (d) welding or bonding an adhesive label orfaceplate to said supported uppermost pouch wall around said aperture;(e) removing said separator member; and (f) completing the contourwelding of said pouch walls so as to form a completed pouch of desiredconfiguration.
 2. The method of claim 1 wherein said pouch contour iscompletely within the contour of said adhesive label characterized inthat said first contour welding step (b) is adjusted so that the weldextends only a short distance past the region of the weld seam whichaffixes said adhesive label and said label which extends beyond thisregion is temporarily lifted clear of said pouch wall as said secondcontour welding step (e) is performed.
 3. A method of manufacturingostomy pouches having an adhesive label or faceplate that attaches thepouch to the body comprising(a) advancing two superposed webs ofweldable plastics sheet material; (b) welding said two webs to form apartial pouch contour said partial contour extending from the top edgeof the pouch past the region to which the adhesive label is affixed; (c)inserting a separator member into the partially contour welded pouch tofunction as a base for the uppermost pouch wall; (d) producing anaperture in said supported uppermost pouch wall, said aperture beingwithin the area of said partial contour weld; (e) welding or bonding anadhesive label or faceplate to said supported uppermost pouch wallaround said aperture; (f) removing said separator member; and (g)completing the contour welding of said pouch walls so as to form acompleted pouch of desired configuration.
 4. The method of claim 3wherein said pouch contour is completely within the contour of saidadhesive label characterized in that the portion of said label whichextends beyond the region of the initial partial contour weld istemporarily lifted clear of said pouch wall as said second contourwelding step (g) is performed.